System and method for managing health data

ABSTRACT

A portable data-management system may be easily employed with multiple processing devices by eliminating the need to pre-install additional programs, agents, device drivers, or other software components on the hosts. A portable storage device contains software for a data-management application, which receives and processes test data from a meter that measures an analyte. The portable device may employ an interface protocol that makes the portable device immediately compatible with different operating systems and hardware configurations. Once the portable device is connected to the host, the data-management application can be automatically launched. The convenience and portability of a data-management system may be enhanced by integrating advanced data processing and display features with the portable device. The users may access some advanced presentations of health data without having to launch the data-management application on a separate host.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.60/932,286, filed May 30, 2007, U.S. Provisional Application No.61/012,721, filed Dec. 10, 2007, and U.S. Provisional No. 61/012,718,filed Dec. 10, 2007, the contents of which are incorporated entirelyherein by reference.

FIELD OF THE INVENTION

The present invention relates generally to a method and system formanaging health data. More specifically, the present invention relatesto a portable system that securely manages and displays informationassociated with the health of an individual, such as measurements ofglucose in a blood sample.

BACKGROUND OF THE INVENTION

The quantitative determination of analytes in body fluids is of greatimportance in the diagnoses and maintenance of certain physiologicalconditions. For example, individuals with diabetes frequently check theglucose level in their bodily fluids. The results of such tests can beused to regulate the glucose intake in their diets and/or to determinewhether insulin or other medication needs to be administered.

Diagnostic systems, such as blood-glucose systems, may employ aninstrument, such as a meter, to calculate the glucose value in a fluidsample from an individual. Such instruments operate by measuring anoutput, such as current or light, from a reaction with the glucose inthe sample. The test results typically are displayed and stored by themeter. Basic systems allow the user to access the test results directlyfrom the meter via a keypad or other interactive component.

SUMMARY OF THE INVENTION

A portable data-management system is provided for securely managing anddisplaying information associated with the health of an individual, suchas measurements of glucose in a blood sample.

One embodiment provides a system for managing health data, comprising: adata storage system storing health data, data-management software, andan initialization program, the initialization program launching thedata-management software on a processing device and the data-managementsoftware processing the health data on the processing device; and a datacommunications interface providing data communications between the datastorage system and the processing device, wherein, upon establishment ofthe data communications between the data storage system and theprocessing device, the initialization program launches thedata-management software on the processing device without requiringprior installation, on the processing device, of an additional programcomponent associated with the data-management software.

Yet another embodiment provides a system for managing health data,comprising: a portable device including data-management software thatprocesses health data, the portable device having a first softwareconfiguration corresponding to an interface protocol and a secondsoftware configuration specific to the data-management software; and aprocessing device connected to the portable device, wherein uponconnection between the portable device and the processing device, theprocessing device communicates with the portable device according to theinterface protocol, and after the portable device is reconfigured fromthe first configuration to the second configuration, the processingdevice executes the data management software.

A further embodiment provides a method for managing health data,comprising: establishing, for a first time, data communications betweena data storage system to a processing device via a data communicationsinterface, the data storage system storing health data, data-managementsoftware, and an initialization program; executing, on the processingdevice, the initialization program upon establishment of the datacommunications between the data storage system and the processingdevice, without requiring prior installation, on the processing device,of an additional program component associated with the data-managementsoftware; launching, with the initialization program, thedata-management software on the processing device; and processing thehealth data on the processing device with the data-management software.

Another embodiment provides a method for managing health data,comprising: detecting a connection between a portable device and aprocessing device, the portable device containing data-managementsoftware processing health data and having a first softwareconfiguration corresponding to an interface protocol, wherein uponconnection between the portable device and the processing device, theprocessing device communicates with the portable device according to theinterface protocol; reconfiguring the portable device from the firstconfiguration to a second configuration specific to the software; andlaunching the software from the reconfigured portable device.

Yet a further embodiment provides a system for managing health data,comprising: a first device that stores health data, data-managementsoftware, and an initialization program; a second device that processesthe health data with the data-management software; and a datacommunications interface providing data communications between the firstdevice and the second device, wherein upon establishment of the datacommunications between the data storage system and the processingdevice, the initialization program launches the data-management softwareon the processing device without requiring prior installation, on theprocessing device, of an additional program component associated withthe data-management software.

An additional embodiment provides a device for managing health data,comprising: a first housing portion including a data storage system thatstores health data; and a second housing portion including a datacommunications element that provides data communications between thedata storage system and a processing device by connecting with theprocessing device, the processing device processing the health dataaccording to a data-management software, wherein the first housingportion and the second housing portion are connected by a cable thatcommunicates signals between the data communications element and othercomponents in the first housing portion.

A further additional embodiment provides a device for managing healthdata, comprising: a first housing portion including a health datamanagement system and a data communications element that provides datacommunications between the health data management system and an externalprocessing device; and a second housing portion that is removablycoupled to the first housing portion, the second housing portionincluding at least one component used by the health data managementsystem.

Still other aspects, features, and advantages of the present inventionare readily apparent from the following detailed description, byillustrating a number of exemplary embodiments and implementations,including the best mode contemplated for carrying out the presentinvention. The present invention is also capable of other and differentembodiments, and its several details can be modified in variousrespects, all without departing from the spirit and scope of the presentinvention. Accordingly, the drawings and descriptions are to be regardedas illustrative in nature, and not as restrictive. The invention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a data-management system including a portable deviceconnected to a processing device.

FIG. 1B illustrates an example of the data-management system of FIG. 1A.

FIG. 1C illustrates an example of a display for the data-managementsystem of FIG. 1A.

FIG. 1D illustrates another example of a display for the data-managementsystem of FIG. 1A.

FIG. 2 illustrates a flowchart for launching a data-managementapplication from a portable device.

FIG. 3 illustrates a data-management system including a portable deviceconnected to a measurement system.

FIG. 4 illustrates a data-management system including a portable deviceand a measurement system both connected to the same processing device.

FIG. 5 illustrates a data-management system including a portable devicethat receives a test sensor and operates with a processor and a userinterface of a processing device.

FIG. 6A illustrates a data-management system including an integrateddevice that provides a measurement system and a user interface.

FIG. 6B illustrates the integrated device of FIG. 6A with a USBinterface element.

FIG. 6C illustrates the integrated device of FIG. 6A receiving a testsensor for receiving a sample.

FIG. 6D illustrates the integrated device of FIG. 6A connectedwirelessly to a plurality of processing devices.

FIG. 7A illustrates a portable device with a USB interface element on anextendible cable.

FIG. 7B illustrates a system with the portable device of FIG. 7Aconnected to a processing device.

FIG. 8A illustrates a view of a portable device with a battery packstored in an end cap.

FIG. 8B illustrates another view of the portable device of FIG. 8A.

FIG. 9A illustrates a view of a portable device with a battery stored ina first end cap and sensor strips stored in a second end cap.

FIG. 9B illustrates another view of the portable device of FIG. 9A.

FIG. 10A illustrates a view of a portable device with a temperaturesensor stored in an end cap.

FIG. 10B illustrates a view of a temperature sensor that may be employedin the end cap of FIG. 10A.

DESCRIPTION OF ILLUSTRATED EMBODIMENTS

A portable data-management system is provided for securely managing anddisplaying information associated with the health of an individual, suchas measurements of glucose in a blood sample. The data-management systemis advantageous to individuals who are actively involved in monitoringand recording measurements of their blood glucose concentrations and/orother analytes or fluids of interest. Individuals who test frequentlycan more easily manage their test results as well as other health datawith the data-management system. The data-management system may beemployed with different processing devices at varying locations, asthere is essentially no need to pre-install additional programs, agents,device drivers, or other software components on the separate processingdevices to operate the data-management system. A portable device storessoftware for a data-management application that receives and processestest results and other health data. The portable device may employ aninterface protocol that is compatible with the operating systems andhardware configurations of different types of processing devices. Oncethe portable device is connected to a processing device, thedata-management application may be launched on the processing device.

The data-management system also may integrate advanced data processingand display features with the portable device. As such, the users mayaccess some advanced presentations of health data without launching thedata-management application on a separate processing device. Inaddition, the data-management system may integrate other functions, suchas an analyte measurement function, with the portable device.

Due to the portability of the data-management system, thedata-management system also addresses issues related to the security ofdata, such as personal medical information. The data-management systemensures that all data is stored on the portable device in the user'spossession and that no data is transferred to and stored by otherprocessing devices. Thus, a user may use a public computer to interfacewith the portable device and no data will remain on the public computerfor others to view. Other security functionality, such asuser-authentication procedures, may also be implemented to enhancesecurity data. Furthermore, the data-management system may also preservedata integrity during the transfer of data between the portable deviceand other devices.

FIG. 1A illustrates a data-management system 10 including a processingdevice 100 and a portable device 200. The processing device 100 may be adesktop or laptop personal computer (PC), a handheld or pocket personalcomputer (HPC), a compatible personal digital assistant (PDA), a smartcellular phone, or the like. In addition, the processing device 100 mayemploy any operating system and configuration. If the processing device100 is a desktop or laptop personal computer, the operating system maybe a version of Microsoft® Windows®. Alternatively, if the processingdevice 100 is a PDA, the operating system may correspond with those ofPALM® handhelds from Palm, Inc., or Blackberry® devices from Research inMotion Limited. In general, the processing device 100 includes aprocessor 110 that is capable of receiving and executing any number ofprogrammed instructions. In addition, the processing device 100 istypically operated with a display 120 and a keyboard 130, and/or otherinput/output elements, which may be external to, or integrated with,other components of the processing device 100.

As described in greater detail below, the portable device 200 may beemployed in combination with hosts that can execute tasks but that arenot full-function processing devices. Such hosts may include taskspecific devices such as printers, display devices, fluid analyte meters(e.g., blood glucose meters), or the like. In general, while aparticular configuration of the data-management system may be described,other configurations may be used including those employing other hosts,storage devices, and additional components.

The portable device 200 may be sized to be easily carried, transported,and stored by an individual. The portable device 200 may include amemory, or data storage, 220, such as flash memory, ElectricallyErasable Programmable Read-Only Memory (EEPROM), or the like. The memory220 may be configured to include a combination of storage technologies.The memory 220 stores data-management software 210 associated with thedata-management system 10. The data-management software 210 may be acollection of programs or computer code that receives and processesmeasured data and/or other input. The data-management software 210processes and/or displays this input in a manner that is desired orselected by the user or other individuals. This information may be usedby a user, home care provider (HCP), a physician, and/or otherindividuals. As discussed previously, the measured data may includeinformation from the testing of an analyte including the concentrationof glucose and/or other analytes in a person's blood or other fluid. Thesoftware 210 can provide the advanced displays and data processing thatmay be required by a user who tests multiple times a day (e.g., fromabout six to about ten times a day). For example, the software 210 mayinclude a product similar to WINGLUCOFACTS® Diabetes Management Softwareavailable from Bayer HealthCare LLC (Tarrytown, N.Y.). As such, thesoftware 210 may provide a complete tool kit that receives and storestest results from a blood glucose-measurement system, receives andstores other testing information, such as test times and meal markers,tracks test results in an electronic logbook, calculates averages andprovides other statistical analysis, summarizes and provides feedback onthe test results, provides a customizable graphical user interface,displays user-friendly charts and graphs of the test results, trackstest results against user-specific target ranges, provides predictiveanalysis, and/or sends data to healthcare professionals via fax, email,or the like. FIG. 1C illustrates an exemplary display 120A presentingtest results from a blood glucose-measurement system in an electroniclogbook format, while FIG. 1D illustrates an exemplary display 120Bpresenting similar data as a graphical trend analysis. The memory 220may also include other software in addition to the software 210.

The data-management system 10 is not limited to receiving and managinginformation from the testing of an analyte, such as blood glucose.Indeed, the data-management system 10 may receive data from othersystems or devices that measure and/or record health data and do notrequire analyte testing, such as body-temperature measurements,blood-pressure measurements, heart rate measurements, blood-oxygencontent measurements, breathing measurements for chronic obstructivepulmonary disease (COPD) analysis, weight measurements for analyzingLasix use, or the like.

The data-management software 210 may include a combination of softwareprograms or components. In FIG. 1A, the data-management software 210includes a startup or initialization program 212 that initiates thedata-management application. The startup program 212 can identify therelevant capabilities and platform of the processing device 100 so thata platform-compatible application may be selected and launched forexecution on the processing device 100. As such, the software 210 may becompatible with one or more platforms/operating systems. Greatercompatibility of the software 210 enhances the portability of thedata-management system 10.

In addition, the software 210 may employ data storage 214, such as anembedded database, for receiving and storing test results. Thedata-management system 10 addresses issues related to the security ofdata, such as personal medical information, by ensuring: (1) essentiallyall data is stored and processed on the portable device 200, whichremains in the user's possession; and (2) no readable data ispermanently transferred from the data storage 214 to the processingdevice 100, which other individuals may access. Thus, a user may use apublic computer to interface with the data-management system 10 and nodata remains on the public computer for others to view. Although thedata-management system 10 may temporarily transfer data to RAM or othersimilar storage on the processing device 100, a cleanup or terminationprocedure in the software 210 ensures that any such transferred data isremoved from the processing device 100 when execution of the software210 is terminated. However, as described further below, the software 210may be executed directly from the portable device 200, so that nomemory, e.g. RAM, on the processing device 100 is used to hold any dataeven temporarily.

If a particular processing device 100 is trusted by a user and/or isfrequently employed by the user, the user may register the processingdevice 100 with the portable device 200 to allow data transfer to theprocessing device 100. A unique device identifier for the processingdevice 100 may be recorded on the portable device 200, so that theportable device 200 can recognize the processing device 100 and permitdata transfer to the processing device 100.

Data security may also be enhanced by employing the data storage 214(e.g., an embedded database) that can only be accessed or decrypted bythe data-management software 210. Furthermore, the software 210 may alsoinclude programs or components, such as user-authentication routines,that protect data integrity and security. When the data-managementsoftware 210 launches, it may immediately prompt the user for a user IDand password, personal identification number (PIN), and/or otherauthentication information. The user is only allowed access to data onthe portable device 200 if the response to the security promptcorresponds with authentication information stored with thedata-management system 10. A user-authentication routine may also beemployed to permit data to be transferred from the portable device 200to the processing device 100.

In addition, a memory map may be employed where the memory 220 isconfigured to have multiple security levels. In other words, areas ofthe memory 220 are designated for different levels of access andmanipulation, e.g., some areas may be more restricted than others. Forexample, a first layer may permit open access for data writes, deletes,and changes, while a second layer may be completely unchangeable. Assuch, a software kernel, core programs, critical permanent data, and thelike may be stored on the second layer to protect the software and thedata from corruption or deletion.

As discussed previously, the memory 220 may be configured to include acombination of storage technologies. Accordingly, the software kernel,the data-management software 210, and the like may be stored on anEEPROM or other primary device. The data-management software 210 islaunched on the processing device 100 from the EEPROM. Meanwhile, dataprocessed by the data-management software 210 is stored on a separateflash memory or other memory device on the portable device 200.

As discussed previously, the portable device 200 may include a flashmemory device, such as a universal serial bus (USB) flash drive or amemory card. USB flash drives are also known as thumb drives, handydrives, flash sticks, or jump drives. Memory cards may have a variety offormats, including PC Card (PCMCIA), CompactFlash (CF), SmartMedia(SM/SMC), Memory Stick (MS), Multimedia Card (MMC), Secure Digital Card(SD), xD-Picture Card (xD), Intelligent Stick (iStick), ExpressCard,some variation thereof, or the like. Flash memory devices may employnon-volatile memory so that the software associated with thedata-management software 210 may be retained in the portable device 200even when the portable device 200 receives no power. The portable device200 may employ other storage media, such as floppy disk or optical disc(CD, DVD, Blu-ray disc).

In some embodiments, the memory 220 in the portable device 200 mayinclude execute-in-place (XIP) memory, such as NOR (NOR digital logicgate) flash memory, so that the data-management software 210 stored onthe memory 220 can be executed directly without the need to copy theminto RAM on the processing device 100. Accordingly, the data-managementsystem 10 can secure the data by ensuring that essentially all data isstored and processed by a data-management system 10 running off aportable device in the user's possession and that essentially no data istransferred to other processing devices. Thus, a user may use a publiccomputer to interface with the system and no data will remain on thepublic computer for others to view.

The portable device 200 may interface with the processing device 100 ina convenient plug-n-play (PnP) approach. The interface enables datacommunications between the portable device 200 and any processing device100 and penults the data-management software 210 to be used with theprocessing device 100. In particular, the portable device 200 has aninterface element 250 that is compatible with an interface element 150on the processing device 100. The portable-device interface element 250may physically engage the processing-device interface element 150 toform a hardware interface. In other words, a physical or wiredconnection between the processing device 100 and the portable device 200may be employed. FIG. 1B illustrates a portable device 200A physicallyconnected, e.g., plugged in, via interface elements 150/250 to aprocessing device 100A, which is a laptop PC with a display screen 120and a keyboard 130. The portable device 200 may be a USB flash drive,and the processing-device interface element 250 may be a USB connectorthat is received into a USB port, which acts as the processing-deviceinterface element 150 on the processing device 100. Thus, the portabledevice 200 employs a USB mass-portable device (USB MSD) configurationthat enables communication between the processing device 100 and theportable device 200 according to a set of standard computingcommunications protocols. The USB connector on the portable device 200is easily inserted into and removed from the USB port on the processingdevice 100. In addition, adapters may be required to enable connection,for example, between the portable device 200 and a processing device 100employing mini-USB, micro-USB, or the like. While FIG. 1A shows a singleinterface element 250, the portable device 200 may include more than oneinterface element 250 to enable connections according to more than oneinterface technology.

USB ports appear on most conventional desktop and laptop PCs, forexample, and the USB mass storage standard is supported natively bymodern operating systems such as Microsoft® Windows®, Mac OS®, Linux,and other Unix-like systems. As USB communications are nativelysupported by a wide variety of devices, additional programs, agents,device drivers, or other software components do not have to be installedlocally on the processing device 100 to enable communication with themass-portable device (USB MSD) configuration of the portable device 200.

The portable device 200 also may be a Secure Digital (SD) memory cardwith a series of contacts that act as the interface element 250. Theprocessing-device interface element 150 may be an expansion slot thatreceives the contacts of the memory card. The processing device 100 andthe portable device 200 may comply with SDIO (Secure Digital InputOutput) interface specifications. Other memory card formats havingdifferent interface specifications may be employed. However, having anSDIO is advantageous because many processing devices such as PDAs, HPCsand smart cellular phones include an expansion slot that is SDIOcompatible.

Additionally or alternatively, the interface elements 150 and 250 alsomay enable the processing device 100 and the portable device 200 tocommunicate via a radio-frequency (RF) link (e.g., a short-range RFtelemetry), such as Bluetooth® wireless technologies, Zigbee, Z-Sense™technology, FitSense, BodyLAN™ system, and other RF technologies. RFtechnologies such as Bluetooth® enable external devices to communicatewirelessly with, for example, laptop personal computers and mobilephones. Other wireless, or non-physical, communication technologies,such as infrared (IR) links, also may be used.

Preferably, the storage service 200 employs an interface element 250that is compatible with at least one interface technology, or protocol,such as USB, SD, or Bluetooth® technology. If a widely-used interfacetechnology is used, the processing device 100 is more likely to providenative support for the interface with the storage service 200. In thisway, the data-management software 210 on the portable device 200 may beimmediately executed on different types of processing devices 100 havingvarying operating systems and hardware configurations, making thedata-management system 10 more portable.

The flowchart of FIG. 2 illustrates how the data-management software 210on the portable device 200 may be implemented on the processing device100. In act 302, the processing device 100 is initially connected to theportable device 200. As discussed previously, the processing-deviceinterface element 150 and the portable-device interface element 250 mayestablish this connection according to an interface technology. Forexample, the user may insert a USB connector on the portable device 200into a USB port on the processing device 100.

As also discussed previously, the processing device 100 may providenative support for the interface technology employed by the portabledevice 200. Thus, the processing device 100 can immediately communicate,in act 304, according to the existing configuration of the portabledevice 200. If the portable device 200 employs a USB MSD configurationand the processing device 100 supports this configuration, communicationis established automatically between the processing device 100 and theportable device 200. Due to the wide use of USB interfaces, additionalprograms, agents, device drivers, or other software components do notgenerally have to be pre-installed on the processing device 100 to makethe processing device 100 compatible with the USB MSD configuration onthe portable device 200.

In act 306, the processing device 100 detects the portable device 200.In FIG. 1A, the data-management software 210 includes the startupprogram 212. In act 308, the startup program 212 may be launched oncethe processing device 100 detects the portable device 200. The startupprogram 212 may be launched automatically or upon input from the user,another person, or another component. Many operating systems provide anauto-launch feature that allows the system to take some actionimmediately upon the insertion of removable media, such as a CD-ROM,DVD-ROM, or flash media. The processing device 100 may employ a versionof the Microsoft® Windows® operating system that provides the AutoRun,or AutoPlay, feature that automatically launches the startup program212. For some processing devices 100, such as those that employ theMicrosoft® Windows® operating system, the portable device 200 may firsthave to announce to the processing device 100 that it is a non-removabledevice before the auto-launch feature of the operating system istriggered to run the startup program 212.

In act 310, the startup program 212 reconfigures the portable device 200from the initial USB MSD configuration to a new configuration specificto the data-management software 210. The new data-managementconfiguration allows the data-management application to be launched andoperated in combination with the processing device 100, in act 312. Thedata-management configuration also supports related functions such asmanaging updates to the data storage 214.

Reconfiguring the portable device 200 from the more universal USB MSDconfiguration to the specific data-management configuration can preventor inhibit other applications on the processing device 100 fromaccessing the files and data on the portable device 200, thereby makingthe data-management system 10 more secure. If the processing device 100employs the Microsoft® Windows® operating system, the Windows® Explorerprogram, which provides a graphical user interface for accessing thefile systems, is unable to access the files on the portable device 200when the portable device 200 has been reconfigured specifically for thedata-management application. This reconfiguration may occurautomatically upon connection between the portable device 200 and theprocessing device 100, thereby preventing non-designated applications onthe processing device 100 from accessing any data on the portable device200.

Due to the plug-n-play aspects of the interface between the processingdevice 100 and the portable device 200, the processing device 100 andthe portable device 200 may be connected or disconnected by the user atany time. As such, the data-management system 10 also ensures that thedata or software on the portable device 200 is not corrupted when theportable device 200 is connected or disconnected from the processingdevice 100. Checksum and/or data commit routines may be employed toensure that data is successfully transferred and stored, thus promotingthe preservation of data integrity. In addition, as discussedpreviously, when the portable device 200 is disconnected, thedata-management software 210 may perform a clean-up or terminationprocedure to remove any data stored temporarily on the processing device100, e.g., RAM, and exits gracefully.

Although the portable device 200 and the data-management software 210stored thereon may be compatible with a variety of processing devices100 having different operating systems, the data-management system 10may also employ another processing device 100 that acts as abase-station. The portable device 200 may connect with the base-stationprocessing device using the interface technologies described herein. Thebase-station processing device may provide a repository for longer termstorage of data downloaded from the portable device 200. In addition, amaster version of the data-management application may be launched fromthe portable device 200 with the base-station processing device. Forexample, the base-station processing device may be an individual's homePC.

In addition, the portable device 200 may be provided with an expansionport that can receive additional devices, such as an SD memory card. Theinterface at this expansion port operates similarly to the otherinterfaces described herein. In particular, the interface may employ anSDIO interface to accept an SD card. The additional memory on the SDcard can be used to store a larger database for test results.

In addition to storing data, such as test results from a bloodglucose-measurement system and other health data processed by thedata-management software 210, the portable device 200 may be employed toincorporate the function of a portable medical records device, due toits portability and compatibility. As such, the portable device 200 maybe used to facilitate the sharing of important information withemergency medical technicians (EMT's), doctors, other health careproviders, or the like.

In a particular embodiment, the portable device 200 may provideimportant information during emergency situations. If the user isunconscious or otherwise unable to communicate with a care giver, thecare giver may connect the portable device 200 with a processing device100 via interface element 250 and once the data-management software 210is launched, important information may appear on a splash screen orinitial screen. This type of functionality is possible, because theportable device 200 is highly compatible with a variety of processingdevices 100, and the care giver does not have to pre-install softwarecomponents on the processing device 100 to launch the software 210.

In some cases, the data-management system software 210 may bedistributed to the health care community, so that data on the portabledevice 200 may be accessed, if authorized, with the data-managementsystem software 210 installed on the health care provider's processingdevice 100, e.g. PC. For security purposes, data may be encrypted sothat it may only be read with a decryption key on the health providerprocessing device. If an instance of the software 210 is already runningon the processing device 100, the software 210 on the portable device200 may be prevented from launching so that two instances of thesoftware 210 are not running. As the portable device 200 and processingdevice 100 may have different versions of the data-management systemsoftware 210, a procedure may be required to reconcile the differentversions. Different versions of the software may organize and store datadifferently and/or collect different types of data. In other words, thestructure of the data storage 214 and the types of data stored thereinmay depend on the version of software 210. For example, if the healthcare provider's processing device has a newer version of the software210, the newer version may be developed to be backward compatible witholder versions of the software 210 and can operate on the data on theportable device 200. If, however, the health care provider's processingdevice 100 has an older version of the software 210, the older version210 may terminate and the newer version on the portable device 200 maybe launched on the health care provider's processing device 100. Othertechniques for reconciling different versions may be employed. Forexample, the software 210 may be developed to provide a base set offunctions that always operate the same way and to structure certainbasic types of data, e.g., fluid analyte measurements, in the same way,so that at least some aspects of the software 210 are unchanging andthus forward and backward compatible.

In general, the types of data that can be stored and shared with otherindividuals, such as health care providers, include, but are not limitedto: name and address information; data tracked for a disease state(logbook information, daily tracking for chronic illnesses andmeasurable markers, measurements collected over the last 12 hours,etc.); comorbidity data; last dose of insulin or other medication taken;primary doctor's name and contact information; information on pastvisits to a doctor; a living will; information on a health care proxy;insurance information; allergy information; and other user-providedinformation. Alternatively or additionally, information can be providedon a sticker or other label affixed to the portable device 200.

To preserve the user's privacy, information shared through the portabledevice 200 is strictly controlled by the user. As a further techniquefor controlling shared data, the data-management software 210 mayprovide multiple levels of access so that certain types of data are onlyaccessible to certain individuals/organizations. For example, an EMT mayonly be able to access information such as doctor's information and datagenerally available on a medical bracelet. In other words, the softwareprovides very basic functionality, e.g., displaying a single splashscreen, to present less sensitive personal information to those withouthigher authority. Meanwhile, a doctor may be able to access moresensitive health-related information. Furthermore, greater access may beprovided to relatives or close care givers, e.g., parents of a childwith diabetes.

As described previously, the portable device 200 may include a varietyof interfaces 250 to connect and communicate with a variety of devices.In addition to connecting with a processing device 100 to launchdata-management software 210 as described previously, the portabledevice 200 may employ its communication capabilities to connectremotely, e.g., over a network, with external systems to provide theuser with a wider range of functionalities and features. In someembodiments, these external systems may provide a host function thatmanages the communication between the portable device 200 and theseexternal systems. These external systems may execute aspects of thedata-management software 210 or other software components stored on theportable device 200 to enable the communication between the portabledevice 200 and the external systems. Alternatively, these externalsystems may store the necessary software components locally.

Accordingly, the portable device 200 may connect to an intermediatedevice, such as a PC with access to the Internet or a mobilecommunications device with access to a cellular network, to transmitdata remotely to other individuals, e.g., health care providers. Assuch, a user does not have to connect the portable device 200 directlywith the other individual's processing device 100 to share data. Thehealth data stored on a portable device 200 is therefore easily sharedwith other individuals, including health care specialists who may belocated in distant or remote locations. This feature may be particularlyadvantageous for users unable to a health care provider's facilities dueto health problems, distance, cost, etc. Moreover, this feature enhancesthe health care provider's ability to monitor a user's health data withgreater frequency and immediacy. The transmission of the data may bemanaged by the intermediate device, which may include a processor toexecute the appropriate software components stored on the intermediatedevice or on the portable device 200.

In addition, the portable device 200 may connect to an intermediatedevice to receive field upgrades to the data and/or software stored onthe portable device 200. For example, the portable device 200 mayconveniently receive an updated/patched version, or even a completelynew version, of the data-management software 210 by connecting to aremote download server through a networked PC or a mobile communicationsdevice. As a further example, the portable device 200 may receive new orupdated parameters for the execution of software on the portable device200. In some embodiments, new programs or features for thedata-management system 10 may be received, e.g., purchased, from aremote download server. Optional features that may customize orpersonalize the graphical user interface for the data-managementapplication may be available through a system accessible through theInternet. To maintain the integrity of the data and software on theportable device 200, data or software downloaded via field upgrade maybe validated before being employed in the portable device 200. Forexample, checksum routines may be employed to confirm that data orsoftware has been successfully downloaded in its entirety. The fieldupgrade may be managed by the intermediate device, which may include aprocessor to execute the appropriate software components stored on theintermediate device or on the portable device 200. Additionally oralternatively, the portable device 200 may include a processor that canlocally execute software components to manage aspects of the fieldupgrade. For example, the processor on portable device 200 may preservedata integrity on the portable device 200 according to a data updatefile (DUF) or other component that ensures that the software has beensuccessfully downloaded. For additional data security, the DUF beemployed with data encryption/decryption.

As discussed previously, embodiments of the portable device 200 mayemploy a USB interface to connect to a variety of devices. Inconventional systems, standard USB is designed to provide connectivitybetween a processing device and peripheral devices, where the processingdevice acts as a host and the USB-enabled peripheral devices act asslaves. In general, with standard USB, only the USB host can initiatedata transfers to the connected USB peripheral device, and the USBperipheral device can only respond to instructions given by the host.Thus, a USB-enabled peripheral device is not able to connect with otherUSB-enabled peripheral devices over a peer-to-peer communicationchannel. In FIG. 1B, where the processing device 100 is a laptop PC, onemay consider the laptop PC to be a host and the portable device 200 tobe a peripheral device. Once the software 210 is launched on theprocessing device 100, the processing device 100, via the software 210,may control the execution of program instructions and any data transferwith the portable device 200.

In other embodiments, however, the portable device 200 may includeprocessing capabilities to act as a host. Therefore, the portable device200 is not limited to the role of a slave as a peripheral deviceaccording to standard USB. In other words, the portable device 200 cancommunicate with a larger variety of devices via peer-to-peercommunication, including devices that are conventionally considered tobe peripheral devices.

For example, the portable device 200 may employ the USB 2.0specification and USB On-The-Go (USB OTG), which is a supplement to theUSB 2.0 specification. The USB OTG functionality enables the portabledevice 200 to communicate with other devices employing USB OTG. When twodevices with USB OTG functionality connect with each other directly, aHost Negotiation Protocol (NHP) enables either one of the two devices tobe a host. The NHP also enables the two devices to exchange host/slaveroles. When a physical connection between two devices with USB OTG isestablished, one of the devices assumes the role of the host and powersup the USB V_(BUS) with 8 mA current, so that USB data communication isrealized between the two connected devices. A Session Request Protocol(SRP) may be used to prompt the host to turn on the USB V_(BUS). Thecommunication between the two devices is bi-directional or duplex, sodata can be exchanged between the two devices. The communication canprovide either low speed transfer (e.g., approximately 1.5 Mbits/sec),full speed transfer (e.g., approximately 12 Mbits/sec), or high speedtransfer (e.g., approximately 480 Mbits/sec). Advantageously, USB OTGfunctionality is configured for use with battery-powered devices andtries to minimize power consumption. In this regard, the USB V_(BUS) canbe turned on and off by the host using the SRP.

It is also noted that if the portable device 200 in FIG. 1A includes USBOTG functionality and connects to a processing device 100 (without USBOTG), the processing device 100 and the portable device 200 cancommunicate via standard USB and the processing device 100 generallyoperates as the host as described previously. Other portable devices mayemploy communication protocols that provide advantages similar to thoseof USB OTG.

In an implementation of USB OTG, the portable device 200 may beconnected directly with a USB-enabled printer and the data from theportable device 200 can be automatically printed. The portable device200 may dynamically create ready-to-print or printable files and maysend the files to a printer via the USB connection.

Device drivers and/or other software components may be required for theportable device 200 to interact with another device. For example, aprinter driver may be required to print data that is uploaded to aprinter. Thus, to print files, the portable device 200 may store andaccess the printer driver when the portable device 200 connects to theprinter to print data. Because it may not be possible to installadditional device drivers and/or other software components to theportable device 200 with USB OTG after the portable device 200 ismanufactured, the portable device 200 may only be compatible with apreselected set of devices, where drivers for the set of devices wereinstalled onto the portable device 200 during manufacturing. A list ofcompatible devices may be stored on the portable device 200, so that theportable device 200 can determine whether it is compatible with a givendevice.

In another example, a first portable device 200 with USB OTG cancommunicate directly with a second portable device 200, where one of theportable devices assumes responsibility as a host. As such, in oneapplication, when a user wants to replace an old portable device with anew portable device, the data and configuration on the old portabledevice can be transferred easily and directly to the new portabledevice. In another application, the functionality available with thefirst portable device 200 may be shared with the second portable device200, or vice versa. For example, the second portable device 200 mayinclude interface elements that employ USB as well as an RF wirelessprotocol not available on the first portable device 200. However, if thefirst portable device 200 connects to the second portable device 200 viaUSB, the first portable device 200 may have access to the RF wirelessprotocol on the second portable device 200.

Data, such as test results from a blood glucose-measurement system, maybe received by the data-management system 10 according to a variety oftechniques. As the previous discussion of USB OTG indicates, theportable device 200 is not limited to interfacing with processingdevices for launching software. Thus, in FIG. 3, the portable device 200may connect directly with a measurement system 20 to enable data to bedirectly downloaded from the measurement system 20 onto the portabledevice 200.

FIG. 3 illustrates an exemplary measurement system 20 including a meter500 with a port 502 for receiving and analyzing a fluid sample on a testsensor 400. The test sensor 400 is configured to receive a fluid samplethat is analyzed using the meter 500. Analytes that may be analyzedinclude glucose, lipid profiles (e.g., cholesterol, triglycerides, LDLand HDL), microalbumin, hemoglobin A₁C, fructose, lactate, or bilirubin.Analyte information may, such as analyte concentrations, may bedetermined. The analytes may be in a whole blood sample, a blood serumsample, a blood plasma sample, other body fluids like ISF (interstitialfluid) and urine, and non-body fluids.

The test sensor 400 includes a fluid-receiving area (not shown) forreceiving a fluid sample. A user may employ a lancet or a lancing deviceto pierce a finger or other area of the body to produce a fluid sampleat the skin surface. The user may then collect this sample (e.g., bloodsample) by placing the test sensor 400 into contact with the sample. Thefluid-receiving area may contain a reagent that reacts with the sampleto indicate the information related to an analyte in the sample, such asanalyte concentration.

The test sensor 400 may be an electrochemical test sensor. Anelectrochemical test sensor typically includes a plurality of electrodesand a fluid-receiving area that contains an enzyme. The fluid-receivingarea includes a reagent for converting an analyte of interest (e.g.,glucose) in a fluid sample (e.g., blood) into a chemical species that iselectrochemically measurable. The reagent typically contains an enzyme,such as glucose oxidase, which reacts with the analyte and with anelectron acceptor such as a ferricyanide salt to produce anelectrochemically measurable species that can be detected by theelectrodes. Other enzymes may be used to react with glucose such asglucose dehydrogenase. In general, the enzyme is selected to react withthe desired analyte or analytes to be tested so as to assist indetermining an analyte concentration of a fluid sample. If theconcentration of another analyte is to be determined, an appropriateenzyme is selected to react with the analyte.

Alternatively, the test sensor 400 may be an optical test sensor.Optical test sensor systems may use techniques such as transmissionspectroscopy, absorption spectroscopy, diffuse reflectance, fluorescencespectroscopy, fluorescence resonance energy transfer, combinationsthereof, and others for measuring the analyte concentration. Anindicator reagent system and an analyte in a sample of body fluid reactto alter light that is directed to the sensor 400. The degree of lightalteration is indicative of the analyte concentration in the body fluid.

Some commercially available test sensors that may be used include thosethat are available commercially from Bayer HealthCare LLC (Tarrytown,N.Y.). These test sensors include, but are not limited to, those used inthe Ascensia® CONTOUR® blood glucose monitoring system, the Ascensia®BREEZE® and BREEZE®2 blood glucose monitoring system, and the Ascensia®Elite® and Elite® XL blood glucose monitoring system. Other testsensors, in addition to the ones listed above, may be incorporated intothe methods and systems of the present invention.

In FIG. 3, the meter 500 receives and engages the test sensor 400. Themeter 500 measures the concentration of analyte for the sample collectedby the test sensor 400. The meter 500 may include contacts for theelectrodes to detect the electrochemical reaction of an electrochemicaltest sensor. Alternatively, the meter 500 may include an opticaldetector to detect the degree of light alteration for an optical testsensor. To calculate the actual concentration of analyte from theelectrochemical or optical reaction measured by the meter 500 and togenerally control the procedure for testing the sample, the meter 500employs at least one processor 510, which may execute programmedinstructions according to a measurement algorithm. Data processed by theprocessor 510 may be stored in memory 520. Furthermore, the meter mayhave a user interface 570 which includes a display (e.g., aliquid-crystal display or the like). Pushbuttons, a scroll wheel, touchscreens, or a combination thereof, may also be provided as a part of theuser interface 570 to allow a user to interact with the meter 500. Thedisplay typically shows information regarding the test results, thetesting procedure and/or information in response to signals input by theuser.

Although the meter 500 can store test results and provide a userinterface 570 to display test results, the data-management software 210on the portable device 200 provides more advanced functionality formanaging, processing, and displaying test results and relatedinformation. Therefore, the test-related data collected by the meter 500may be downloaded to the portable device 200 for use with thedata-management software 210. In FIG. 3, the meter 500 includes aninterface element 550 that enables the meter 500 to connect with theportable device 200 via the portable-device interface element 250.

The meter-interface element 550 and the portable-device interfaceelement 250 may employ the interface technologies described previously.A USB interface may connect the portable device 200 with the meter 500.The transfer of data between the meter 500 and the portable device 200may require a host function, such as the USB host function, to beemployed on the portable device or meter 500, which includes a processor510. As such, the download of data is managed by the portable device 200or the meter 500 to execute appropriate software components stored onthe meter 500 or the portable device 200. Data transferred, e.g., aseries of blood-glucose readings, can be organized with timestamps orsequence numbers to ensure appropriate data storage and analysis by theportable device 200.

In addition to the interfaces described previously, other communicationprotocols for data transfer via interface elements 250 and 550 may beemployed. For example, radio frequency identification (RFID) technologycan provide an interface for data transfer to the portable device 200from the meter 500. In particular, interface element 250 on the portabledevice 200 may include an RFID antenna and RFID circuitry. Meanwhile,the interface element 550 on the meter 500 may include the correspondingRFID circuitry, so that the meter 500 can be swiped past or scanned bythe portable device 200 to transfer data, such as blood-glucosereadings, to the portable device 200. Less power is required for thetransmitter, e.g., the meter 500, and more power is required for thereceiver, e.g., the portable device 200, to employ this RFID interface.In some embodiments, data in the range of about 56K to about 256K, whichmay correspond for example to about 100 blood-glucose readings, can betransferred at one time.

The RFID technique for transferring data may be employed between theportable device 200 and any other device, such as a processing device100. As described previously, the processing device 100 may be abase-station processing device or a health care provider's processingdevice. Because these processing devices may already include thedata-management software 210, the software 210 does not have to belaunched from the portable device 200 and only stored data, such as dataassociated with blood-glucose readings, needs to be transferred to theprocessing device 100. In this embodiment, the interface element 150 onthe processing device 100 includes the RFID antenna, as the processingdevice 100 acts as the receiver while the portable device 200 acts asthe transmitter. Advantageously, less power is required for the portabledevice 200 in this embodiment.

The portable device 200 may have a power source such as a rechargeablebattery 260, which may be recharged via the connection with theprocessing device 100 or another external device with a power supply.For example, power may be transferred via a USB connection between theprocessing device 100 and the portable device 200. When the portabledevice 200 and the meter 500 are connected, the battery 260 can be usedto recharge the rechargeable battery 560 which powers the meter 500, orvice versa.

As described previously, the portable device 200 may connect to anintermediate device to receive field upgrades to the data and/orsoftware stored on the portable device 200. The portable device 200 mayalso be used to update or add software to the meter 500. In an exemplaryembodiment, a new or updated version of software for the meter 500 maybe downloaded to the portable device 200. This may be accomplished afterthe portable device 200 connects to a remote download server through anetworked PC or a mobile communications device. The new or updatedversion of software may then be downloaded to the meter 500 after themeter 500 is connected to the portable device 100. This download processmay be managed by the portable device 200 or the meter 500.

In FIG. 4, data collected by the measurement system 20 of FIG. 3 may bedownloaded by connecting the measurement system 20 to the processingdevice 100 through processing-device interface element 155, while theportable device 200 is also connected to the processing device 100. Thedata can then be loaded onto the portable device 200 via the processingdevice 100. The connection between the measurement system 20 and theprocessing device 100 may employ the communication interfacetechnologies described previously. For example, the measurement system20 may be received into a second USB port on the processing device 100.In addition, the data-management software 210 running on the processingdevice 100 may be used to enable or facilitate the transfer of data fromthe measurement system 20.

FIG. 5 illustrates another portable device 1100 that incorporates thecomponents and functions of the portable device 200 with the componentsand functions of the meter 500. In particular, the portable device 1100includes a memory 220 storing a software 1110 that may be launched onthe processing device 100 without requiring the pre-installation ofsoftware components on the processing device 100. The software 1110includes a startup program 1111 that launches the software 1110 on theprocessing device 100 in the manner described previously. In addition,the memory 220 may include data storage 1112, such as a database, thatstores data collected or processed with the software 1110. The memory220 may include a universal serial bus (USB) flash drive, a memory card,or the like. The portable device 1100 also has an interface element 250that may connect to the interface element 150 of the processing device100 via USB technology, RF technology, or the like.

In addition, the portable device 1100 may include a port 502 to receivean analyte-test sensor 400. A sample, such as a blood sample, may becollected by the test sensor 400 and may be analyzed as describedpreviously to determine an analyte concentration, such as a bloodglucose concentration. The software 1110 includes programmedinstructions for analyzing the sample received with the analyte-testsensor 400. As such, when the software 1110 is launched on theprocessing device 100, the processor 110 on the processing device 100executes the software 1110 to collect and analyze information from thedetection of an electrochemical or optical reaction when the samplereacts with a reagent on the test sensor 400. Once the processor 110determines test results from analyzing the sample on the test sensor400, the processing device 100 may display the test results on thedisplay 120 associated with the processing device 100. Accordingly, theportable device 1100 and the processing device 100 combine to provide ameasurement system, such as a blood glucose meter, where the portabledevice 1100 provides the port 502 for detecting a reaction on the testsensor 400 and the processing device 100 analyzes the reaction with thesoftware 1110 from the portable device 1100 and displays the testresults. Additionally, the software 1110 may include features of thedata-management software 210 described previously to provide enhanceddata processing and display features on the processing device 100.

The memory 220 of portable device 1100 may include a Secure Digital (SD)card and the portable device 1100 may connect with a processing device100, such as a PALM® handheld or Blackberry® device, via SDIO (SecureDigital Input Output) interface specifications. The portable device 1100may therefore have the form of a SD card with the port 502 for receivinga test sensor 400, and the SD card can be plugged into a processingdevice 100 to provide a measurement system. Alternatively, the portabledevice 1100 may include other types of memory and may connect to theprocessing device via other technologies, such as Bluetooth® wirelesstechnologies.

Additionally, the software 1110 may be Java based so that the portabledevice 1100 can use a web browser as commonly available on mostoperating systems to render, via HTML, a front-end user interface forthe software 1110. Advantageously, the Java based software 1100 isgenerally not dependent on the operating system type, and many devices,such as a PALM® handheld or Blackberry® device, employ web browsers.Thus, the portable device 1100 provides a highly compatible and portableapproach for converting many devices into a measurement system, such asa blood glucose meter. In general, the software launched by the portabledevices described herein may also be Java based programs that areexecutable on web browsers and similar rendering applications.

Like the portable device 1100 of FIG. 5, an integrated device 600 inFIGS. 6A-6D incorporates the components and functions of the portabledevice 200 with the components and functions of the meter 500.Accordingly, the integrated device 600 may receive an analyte-testsensor 400 via the port 502. However, the integrated device 600 alsoincludes a processor 610 that may calculate the concentration of analytein the sample collected by the test sensor 400. Unlike the portabledevice 1100, the integrated device 600 does not require the calculationof analyte to be handled by a processor 110 of a separate processingdevice 100. Rather, the processor 610 in the integrated device 600processes information from the detection of a reaction between thesample and a reagent on the test sensor 400. The test results are storedin the memory 220 of the integrated device 600. As such, the memory 220may have a capacity in the range of about 500 MB to about 2 GB.

In addition, the integrated device 600 includes a user interface 670that may be used to display the test results and to enter input forvarious display options. In particular, the user interface 670 mayprovide further convenience and portability for a data-management system10 by integrating the functionality of the portable device 200 withadvanced data processing and display features. In sum, the integrateddevice 600 integrates the portable device 200 with a user interface 670as well as the components and functions of the meter 500.

Thus, as shown in FIGS. 6B and 6C, an integrated device 600 may be aportable blood glucose meter that provides data processing and displayfeatures. Users may employ the integrated device 600 to provide a bloodsample via test sensor 400 and may access more sophisticatedpresentations of blood glucose test data from the integrated device 600without launching the data-management application on a separateprocessing device 100.

However, as hardware limitations may still prevent all desiredfunctionality to be incorporated into the integrated device 600, theintegrated device 600 retains the ability to launch the data-managementapplication on a larger processing device 100 and to provide the userwith functionality not available on the integrated device. FIG. 6Dillustrates the integrated device 600 connected wirelessly to more thanone processing device 100, including a laptop PC and mobilecommunication devices.

As described above, the integrated device 600 may communicate with, andtransfer data to, a processing device 100 without necessarily launchingthe software 210. Indeed, the processing device 100 may already includethe data-management software 210. In particular, the RFID technique fortransferring data can be employed between the integrated device 600 andthe processing device 100. The interface element 150 of the processingdevice 100 includes the RFID antenna, as the processing device 100 actsas the receiver while the integrated device 600 acts as the transmitter.The integrated device 600 may be swiped past or scanned by theprocessing device 100 to transfer data, such as blood-glucose readings,to the processing device 100. Less power is required for the integrateddevice 600, and more power is required for the processing device 100.Data transferred, e.g., a series of blood-glucose readings, can beorganized with timestamps or sequence numbers to ensure appropriate datastorage and analysis by the processing device 100.

In further applications, the integrated device 600 may transmit data toa processing device 100 that resides remotely on a network. As describedpreviously, various approaches can be implemented to provide networkedcommunications. For example, the integrated device 600 may connect to anintermediate device, such as a PC with access to the Internet or amobile communications device with access to a cellular network, totransmit data remotely to other systems or devices. In otherembodiments, the integrated device 600 may communicate more directlywith a remote system or device. For example, a remote processing device100 may be a server in a centralized health care system that providesfurther processing or storage of data collected by the integrated device600. The centralized health care system may provide a web-based or aclient-server based front end to data-management software 210 running onthe remote processing device 200. Additionally or alternatively, thedata may be shared with health care professionals. Accordingly, totransfer data from the integrated device 600 to the remote processingdevice 100, the integrated device 600 may connect directly via theinterface element 250, for example, to a wireless network or a Wi-Fihotspot. Data encryption and authentication procedures may be employedto ensure data security. In one embodiment, the integrated device 600detects the presence of a wireless network or a Wi-Fi hotspot andautomatically transfers data to the remote processing device 100 througha background process. Alternatively, the integrated device 600 may alertthe user via the user interface 670 that access to the remote processingdevice 100 is available, and the user can initiate data transfer ifdesired.

The integrated device 600 may store a display state for the userinterface 670. For example, functionality may be available on theintegrated device 600 to log testing information and a log book may bedisplayed on the display of user interface 670. The log book functionmay be accessed by selecting a shortcut icon on the screen or selectingthe function through a menu. However, for convenience, when the userdisplays the logbook, the integrated device 600 tracks the state of thedisplay, so that if the device 600 is powered off, enters a standbymode, or is otherwise deactivated during the logbook function, thelogbook function and display can be started automatically when thedevice 600 is activated again. Of course, the display state may also beused for any other function that appears on the display.

Moreover, the display state stored by the integrated device 600 may beused with data-management software 210 that runs on the processingdevice 100. In particular, the user may display some information, suchas a summary of test results, through the user interface 270 of theintegrated device 600. If this particular display remains in the displaystate, the display state may be communicated to the data-managementsoftware 210 on the processing device 100 when it is connected to theintegrated device 600, so that functionality in the data-managementsoftware 210 that corresponds to the display last shown on the device600 may be automatically started. The data-management software 210 mayautomatically start a screen that provides detailed data regarding asummary of test results displayed on the integrated device 600.

In general, the portable device 200 may be integrated with varyinglevels of functionalities, such as user interface features andmeasurement system capabilities. However, any device employingcomponents and functions of the portable device 200 may include a userinterface, even if it does not incorporate components and functions ofthe meter 500.

FIGS. 7A-10B illustrate additional features that may be employed withthe exemplary embodiments described previously. Although these featuresare described with respect to embodiments with a USB interface element250, the features may be applied to embodiments employing othercommunication protocols for interface element 250, as discussedpreviously.

FIGS. 7A and 7B illustrate a portable device 700 which may be similar inmany respects to the portable device 200 described previously. Theportable device 700 includes a USB interface element 250A that mayextend from the body, or a housing portion, of the portable device 700to keep the body from physically interfering with the insertion of theinterface element 250A into a USB port of a processing device 100. Inparticular, a conducting cable 252 of convenient length extends betweenthe interface element 250A and the body 201 of the portable device 700.The conducting cable 252 enables the interface element 250A tocommunicate electrical signals to other components of the portabledevice 700, while the interface element 250A is spaced away from thebody 201 of the portable device 700. To provide convenient storage of anunnecessary length of the conducting cable 252, a portion of theinterface element 250A includes a storage chamber 251. The storagechamber 251 of FIG. 7A includes a spring-loaded cable recoil with aclutch, which draws any slack in the conducting cable 252 into thestorage chamber 251. The conducting cable 252 maintains an appropriateamount of tension, and an additional length of the conducting cable 252can be easily drawn from the storage chamber 251 when extra length isrequired. When the interface element 250A is not in use, it can beconveniently stored in the storage cavity 253 in the body 201 of theportable device 700. FIG. 7B illustrates the portable device 700connected via conducting cable 252 to a processing device 100B, which isa laptop PC.

FIGS. 8A and 8B illustrate an integrated device 800, which may besimilar in many respects to the integrated device 600. The integrateddevice 800 has a USB interface element 250. The integrated device 800may be powered by a connection via the USB interface element 250 toeither a processing device 100, such as a PC, or to a battery pack 260.In FIGS. 8A and 8B, the battery pack 260 is disposed in a cap 202 whichfits over the USB interface element 250. Thus, aesthetically, thebattery pack 260 looks like a cap for the USB interface element 250. Thebattery pack 260 may be positioned within the cap 202 according to afirst orientation, so that when the cap 202 is placed over the USBinterface element 250, the battery pack 260 connects with the USBinterface element 250 and provides power to the integrated device 800.FIG. 8B illustrates the cap 202 in a second orientation where thebattery pack 260 is disposed in an offset position so that the batterypack 260 and the USB interface element 250 are not aligned. Thus, whenin the second orientation, the battery pack 260 does not connect to theUSB interface element 250, enabling the battery power to be saved andthe battery life to be extended. The cap 202 may be transitioned betweenthe first orientation and the second orientation by removing the cap202, turning the cap 202 180-degrees, and placing the cap 202 back overthe interface element 250. The battery pack 260 may include one or morereplaceable batteries. Alternatively, the batteries are not replaceableand are fixed to the cap 202, and thus, the entire cap 202 must bereplaced to employ new batteries.

FIGS. 9A and 9B illustrate another integrated device 900, which may besimilar in many respects to the integrated device 800 describedpreviously. One end of the integrated device 900 includes an USBinterface element 250 with a cap 202. Meanwhile, the other end of theintegrated device 900 includes another cap 203 that stores test sensors400. The caps 202 and 203 are interchangeable. Thus, during operation,the cap 202 is placed over the USB interface element 250 to connect thebattery pack 260 to deliver power, and the cap 203 is removed to provideaccess to the sensor strips 400 for collecting samples. For example, thecap 203 may hold multiple test sensors 400 that may be used to collectsamples, and the test sensors 400 may then interface with the integrateddevice 800 to capture the sample data. However, when the integrateddevice 800 is not in use, the cap 203 may be placed over the USBinterface element 250, and the cap 202 may be placed over the other endof the integrated device 800. The cap 203 may provide a sealing fit overthe ends of the integrated device 800 to promote proper storage of thetest sensors 400.

FIG. 10A illustrates yet another integrated device 1000, which may besimilar in many respects to the integrated device 600. The integrateddevice 1000 includes a USB interface element 250 in a main body 201. Acap 209 may be removably coupled to the main body 201 and placed overthe USB interface element 250. The cap 209 includes a temperature sensor280 and corresponding circuitry 281. The temperature sensor 280 mayinclude a thermocouple, thermistor, thermochromatic sensor, or the like.The temperature sensor 280 measures the temperature at, or near, anouter surface 204 of the cap 209. When the cap 209 is placed over theUSB interface element 250, the temperature sensor 280 is connected tothe interface element 250 and corresponding temperature data istransferred to the processor of the integrated device 1000. In general,the temperature of the main body 201 may not reflect the ambienttemperature, because the main body 201 may retain heat generated by theoperation of the integrated device 1000. The temperature of the mainbody 201 may also be affected by its proximity to other warm or coldbodies. For example, body heat may be transferred to the main body 201when the integrated device 1000 is held in a user's hands or isotherwise carried in proximity to the user's body. Due to the thermalmass of the main body 201, the main body 201 may reach equilibrium withthe ambient very slowly. Because the outer surface 204 of the cap 209has a weak thermal coupling with the main body 201, however, thetemperature measured at, or near, the outer surface 204 is notsubstantially affected by the main body 201. Moreover, the temperatureof the temperature sensor 280 reaches equilibrium with the ambient morequickly than the main body 201. A heat sink may be employed to speed upthe transition to ambient temperature for the outer surface 204. As aresult, the temperature sensor 280 reflects the ambient temperature moreaccurately. The temperature data from the temperature sensor may beemployed to determine the concentration of an analyte in a fluid sample(e.g., blood glucose concentration) according to a reaction with thereagent on the test sensor 400. Because the level of reaction may beaffected by changes in temperature of the reagent, the ambienttemperature can be measured to estimate the temperature of the reagent.As such, the integrated device 1000 may account for the reagent'ssensitivity to temperature and, thus, obtain a more accurate calculationof the concentration of analyte in the sample.

FIG. 10B illustrates a cross-section of a cap 209 with a temperaturesensor 280 that may be employed with the integrated device 1000 of FIG.10A. In particular, the temperature sensor 280 includes a thin membrane205 in a part of an outer wall portion 206 of the cap 209. The thinmembrane 205 has a low thermal mass and a large area-to-thickness ratiothat helps the thin membrane to reach equilibrium with the ambient morequickly. As such, the temperature sensor 280 measures the temperature ofthe thin membrane 205 to achieve a more accurate determination of theambient temperature. To minimize heat conduction to the thin membrane205, the thin membrane 205 may be formed of plastic or the like, and theouter wall portion 206 may be coupled to the rest of the cap 209, sothat there is at least one gap 207 between the outer wall portion 206and the rest of the cap 209. The gap 207 allows ambient air flow aroundthe thin membrane 205 to promote transition by the thin membrane to theambient temperature. Alternatively, the outer wall portion 206 mayprovide a very loose interlocking connection that includes gaps 207 andallows ambient airflow around the thin membrane 205. The thin membrane205 or the outer wall portion 206 may be replaced if either experiencesany damage. The temperature sensor circuitry 281 may include an infrared(IR) sensor to measure the temperature of the thin membrane 205.Alternatively, the thin membrane 205 may include a thermochromicmaterial, which changes color with temperature. The temperature sensor280 in this case may include a light source, such as one or more laserLED's, and a detector, such as one or more photodiodes. The light sourcetransmits photons to the thermochromic material, and the detectorreceives the photons that are reflected from the thermochromic materialand that indicate the color of the thermochromic material. In someembodiments, the circuitry 281 may be housed in the main body 281 ratherthan the cap 209, while the thin membrane 205 or other temperaturesensor structure remains in the cap 209.

While the invention is susceptible to various modifications andalternative forms, specific embodiments and methods thereof have beenshown by way of example in the drawings and are described in detailherein. It should be understood, however, that it is not intended tolimit the invention to the particular forms or methods disclosed, but,to the contrary, the intention is to cover all modifications,equivalents and alternatives falling within the spirit and scope of theinvention.

1-61. (canceled)
 62. A system for securing health data, comprising: ablood glucose meter including: a housing having a port configured toreceive a test sensor therein; a measurement system disposed within thehousing, the measurement system being configured to be coupled with thetest sensor received in the port of the housing, the measurement systemincluding at least one processor that executes program instructions todetermine a glucose concentration measurement of a blood sample receivedby the test sensor; and a data storage system disposed within thehousing, the data storage system including a first memory device storinga data-management application and a second memory device storing healthdata, the health data including glucose concentration measurementsdetermined by the at least one processor of the measurement system; anda processing device configured to (i) establish data communications withthe blood glucose meter via a data communications interface, (ii) readthe data-management application from the first memory device, (iii) readthe health data from the second memory device, and (iv) execute thedata-management application to process the health data, wherein one ormore other applications executing on the processing device is preventedfrom accessing the health data stored in the second memory device of thedata storage system by the blood glucose meter.
 63. The system of claim62, wherein the processing device does not store any component of thedata management application before data communications are establishedbetween the blood glucose meter and the processing device.
 64. Thesystem of claim 62, wherein the processing device processes the healthdata from the second memory without permanently storing the health dataon the processing device.
 65. The system of claim 62, wherein thedata-management application includes a termination component configuredto delete any of the health data transferred to the processing device.66. The system of claim 62, wherein the data-management softwareincludes a termination component configured to delete any of the healthdata read by the processing device.
 67. The system of claim 62, whereinthe second memory device is separate from the first memory device, andwherein second memory device stores health data in an encrypted fashionsuch that the data-management application is required to decrypt thestored health data
 68. The system of claim 62, further comprising a userinterface operable to display at least a portion of the stored glucoseconcentration measurements, and wherein the processing device displaysthe processed health data on a display of the processing device, thedisplayed processed health data being different than the glucoseconcentration measurements displayed on the user interface.
 69. Thesystem of claim 68, wherein the displayed processed health dataincludes: (i) customizable averages based on the health data; (ii)health data in relation to a user-specified target range; (iii) feedbackand predictive analysis related to the health data; or (iv) anycombination of (i), (ii), and (iii).
 70. The system of claim 62, whereinthe processing device is compatible with an interface protocolconfiguration of the blood glucose meter, the interface protocolconfiguration allowing data communication to be established between theblood glucose meter and the processing device, and in response toestablishment of the data communications between the blood glucose meterand the processing device, the blood glucose meter is reconfigured fromthe interface protocol configuration to a software configurationallowing the processing device to read the data-management applicationand the health data from the data storage system, the softwareconfiguration being different from the interface protocol configuration,the software configuration including a security component that controlsaccess by the processing device to the health data in the data storagesystem such that the security component only permits the data-managementapplication access to the health data.
 71. A method for securing healthdata, comprising: receiving a test sensor in a port of a housing of ablood glucose meter such that the test sensor is coupled with ameasurement system of the blood glucose meter; receiving a blood samplevia the test sensor; in response to the receiving the blood sample,executing program instructions, via at least one processor of the bloodglucose meter, to determine a first glucose concentration measurement ofthe received blood sample; storing the determined first glucoseconcentration measurement in a data storage system of the blood glucosemeter, the data storage system including a first memory device storing adata-management application and a second memory device storing glucoseconcentration measurements including the determined first glucoseconcentration measurement; establishing by a processing device, for afirst time, data communications with the blood glucose meter via a datacommunications interface; and in response to the establishing of thedata communications with the blood glucose meter for the first time, (i)reading, with the processing device, the data-management applicationfrom the first memory device; (ii) reading with the processing device,the glucose concentration measurements from the second memory device;and (iii) executing, by the processing device, the data-managementapplication to process the glucose concentration measurements, whereinthe blood glucose meter is configured to prevent one or more otherapplications executing on the processing device from accessing thestored glucose concentration measurements.
 72. The method of claim 71,wherein the processing device does not store any component of thedata-management application before data communications are establishedbetween the blood glucose meter and the processing device for the firsttime.
 73. The method of claim 71, wherein the processing deviceprocesses the glucose concentration measurements without permanentlystoring the glucose concentration measurements on the processing device.74. The method of claim 71, further comprising deleting from a memory ofthe processing device, using a termination component of thedata-management application, the glucose concentration measurements readby the processing device.
 75. The method of claim 71, wherein theprocessing device is compatible with an interface protocol configurationof the blood glucose meter, the interface protocol configurationallowing data communication to be established between the blood glucosemeter and the processing device, and in response to the establishing ofthe data communications between the blood glucose meter and theprocessing device, the method further comprising reconfiguring the bloodglucose meter from the interface protocol configuration to a softwareconfiguration specific to the data-management application, the softwareconfiguration being different from the interface protocol configuration,the software configuration including a security component that controlsaccess by the processing device to the glucose concentrationmeasurements in the data storage system such that the security componentonly permits the data-management application access to the glucoseconcentration measurements.
 76. The method of claim 71, wherein thesecond memory device is separate from the first memory device, andwherein the determined first glucose concentration measurement is storedin the second memory device in an encrypted fashion such that thedata-management application is required to decrypt the stored firstglucose concentration measurement.
 77. The method of claim 71, furthercomprising: displaying, on a user interface of the blood glucose meter,the stored first glucose concentration measurement; and displaying, withthe processing device, the processed glucose concentration measurementson a display coupled to the processing device, the displayed processedglucose concentration measurements being different than the firstglucose concentration measurement displayed on the user interface of theblood glucose meter.
 78. The method of claim 77, wherein the displayedprocessed glucose concentration measurements includes: (i) customizableaverages based on the glucose concentration measurements; (ii) healthdata in relation to a user-specified target range; (iii) feedback andpredictive analysis related to the glucose concentration measurements;or (iv) any combination of (i), (ii), and (iii).